質量安全是血液制品的最關鍵的內容，亦是最基本的要求。藥品生產六大系統(tǒng)實際上已涵蓋了影響藥品質量的各要素。對國內外藥品監(jiān)管和檢查機構針對全球血液制品生產企業(yè)檢查缺陷的收集、梳理與分析，結合血液制品生產質量管理的特點，對血液制品生產質量管理中質量管理系統(tǒng)、設施設備系統(tǒng)、物料系統(tǒng)、生產系統(tǒng)、包裝和標簽系統(tǒng)、實驗室控制系統(tǒng)的管理要點和常見問題進行分析，為血液制品監(jiān)督檢查、企業(yè)持續(xù)提升質量管理水平提供建議和參考。

The quality and safety represent the most crucial aspect and fundamental requirement of blood products. The six major systems of drug production actually covered various elements that affected drug quality. This article collects, sorts out, and analyzes the inspection defects of global blood product production enterprises by domestic and foreign drug regulatory and inspection agencies. Combining with the characteristics of blood product production quality management, it analyzes the management points and common problems of quality management system, facility and equipment system, material system, production system, packaging and labeling system, and laboratory control system in blood product production quality management. The aim is to provide suggestions and references for blood product supervision and inspection, as well as for enterprises to continuously enhance their quality management standards.

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